UPDATE: FDA Warns 17 Lasik Centers About Subpar Reporting

(Includes comment from LCA-Vision, updates stock prices.)

The U.S. Food and Drug Administration has issued warning letters to 17 Lasik vision-correction ambulatory surgical centers after inspections found inadequate reporting systems.

The inspections didn't find problems with the use of Lasik devices at the centers, the FDA said.

"Ambulatory surgical centers that perform Lasik must maintain a robust reporting system as required by law," said Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health. "Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in Lasik procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."

TLC Vision Corp. (TLCV) issued a release Thursday night, saying six of its centers were inspected by the FDA in the past four months. One center was found to need additional written procedures, as outlined in a letter TLC received from the FDA on Aug. 20.

President and Chief Executive James Tiffany said the company responded soon thereafter, adding that, "Neither the inspection nor the observations from the inspection related to device safety or efficacy of the Lasik procedure."

Mike Celebrezze, a spokesman for rival LCA-Vision Inc. (LCAV) said Friday that 14 of the company's centers were visited by FDA officials between June and August, with no reporting errors found. "But they felt our policy for reporting wasn't as strong as they would have liked, so we have revised and updated our policies," he added.

The news comes as laser-vision correction procedures have slumped for more than a year amid the recession. The work typically isn't covered by health insurance.

Shares of TLC were recently up a penny at 29 cents while LCA-Vision was down 4 cents at $5.70.

 
   -By Nathan Becker, Dow Jones Newswires; 212-416-2855; [e-mail];